Paul Levesque, a principal at the management consulting firm MedStar Partners, identifies some key aspects of medical product development. In today's increasingly competitive medical technology market ...

Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of ...

Randomized, controlled clinical trials (RCTs) have traditionally served as the gold standard for evidence generation in support of medical product development and approval. However, it is increasingly ...

On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial ...

The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and ...

The Zacks Medical - Products industry’s revenues are expected to continue to grow due to robust demand for surgeries and procedures, the launch of new products and expansion into new markets. An ...

The Zacks Medical - Products industry is likely to face rising uncertainty amid tariff imposition by the United States.Tariffs reinstated on medical devices — from 10% on most imports to as high as ...